跳至主要内容
临床试验/NCT06001281
NCT06001281招募中不适用

Predictive Value of Soluble CD146 in Patients With Recurrent Glioblastoma Treated by Bevacizumab

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2024年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
55
试验地点
2
主要终点
correlation between soluble CD146 plasma value and patient response (RANO)

研究概览

简要总结

Glioblastoma is the most common malignant primary brain tumor with poor prognosis because of its diffusive and infiltrative nature. The FDA approved the use of the anti-VEGF antibody bevacizumab in recurrent GBM. However, resistance to this anti-angiogenic reagent is frequent and fails to enhance patients' overall survival. The investigators previously identified one novel mechanism responsible for bevacizumab-resistance in CD146-positive glioblastoma (Joshkon et al. Acta Neuropathol Commun, 2022).

Now, the investigators objective is to prospectively monitor the soluble CD146 value in plasma from patients treated by bevacizumab for recurrent glioblastoma.

The investigators will collect plasma at baseline, before the first bevacizumab administration, before the second administration, at the time of first MRI evaluation and at progression. Plasma CD146 value will be analyzed by ELISA.

The investigators expect to confirm the correlation between soluble CD146 value in plasma and patient response to bevacizumab.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - Adult patients with recurrent IDHwt glioblastoma
  • Relapse after standard first line treatment (radio-chemotherapy)
  • Candidate for bevacizumab treatment
  • Able to be monitored by MRI
  • KPS ≥ 60%
  • Written signed consent form

排除标准

  • Pregnancy or breast feeding
  • Life expectancy less than 3 months
  • Bevacizumab in first line treatment
  • Other concomitant life-threatening disease
  • Under legal protection

结局指标

主要结局

correlation between soluble CD146 plasma value and patient response (RANO)

时间窗: first evaluation (2 months)

Soluble CD146 plasma value will be assessed using ELISA. Patient response will be evaluated by MRI and clinical response using the international RANO criteria.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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